Associate Director, Clinical Quality Assurance, Systems
|Location||Woodcliff Lake, NJ|
|Job Type|| Direct-hire/Full-time|
|Compensation||$145-$175,000 + Bonus and LTI|
|Job ID Number||DR9920052008|
The Associate Director, GCP Quality Assurance Systems & Data Integrity, will oversee quality oversight activities of Clinical trial Systems used by Vendors & CROs and lead associated audits and inspection management. This person will manage cross-functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to IT and associated vendor management. This is a high visibility position with great impact potential.
- Lead the conduct of internal clinical System/Process audits and Data Integrity & Access Governance (DIAG) audits as needed.
- Lead the conduct of clinical vendor audits of CROs, laboratories, and other providers to clinical trials by conducting remote audits or on-site audits (as deemed necessary) in the Americas, following company procedures and practices, to verify data integrity, GCP compliance with ICH guidelines and government regulations/guidance.
- Support health authority inspections and preparation activities related to IT aspects.
- Compile and analyze audit metrics to communicate trends to business group.
- Bachelor’s degree in associated functional disciplines including IT, Data Sciences, Pharmaceutical Science and others.
- 8+ years of pharmaceutical company experience preferably in Clinical data management, Clinical Systems or related area.
- Minimum of 3-6 years of Quality Assurance auditing experience with at least 2 years conducting Systems and clinical vendor audits.
- Experience with inspection management including leading inspection strategy.
- Knowledge of general GCP, clinical trial methodology, and specific knowledge of applicable regulations/guidance (including 21 CFR Part 11) and ICH Guidelines related to clinical computer systems.
- Clinical systems orientation with familiarity of emerging technologies such as cloud computing, mobility, and big data and its applicability to clinical research.
- Strong analytical skills and report writing skills.
- Ability to demonstrate tact as a representative of the CQA Department.
- Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
- Ability to Travel (approximately 20%).
- Location: Woodcliff Lake, NJ (WCL) or remote. For remote: seeking candidates that are within driving distance to WCL. Candidate should be willing to work at WCL on as needed basis and on short notice for Health Authority inspections.